Safe-Point Vac, Safe-Point M-D Blood Collection Systems
FDA 510(k) K001965 · North American Medical Products, Inc.
510(k) numberK001965
Submission
- Device name
- Safe-Point Vac, Safe-Point M-D Blood Collection Systems
- Applicant
- North American Medical Products, Inc.
Albany, NY, US - Received
- June 28, 2000
- Decision date
- February 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
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| K896072 | D.L. Scope OphthalmoscopeHLJ · Traditional | 11/27/1989SE |
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Questions and answers
When was Safe-Point Vac, Safe-Point M-D Blood Collection Systems cleared by the FDA?
Safe-Point Vac, Safe-Point M-D Blood Collection Systems (K001965) received a 510(k) decision of Substantially Equivalent on February 2, 2001, 219 days after the submission was received.
What is the product code of K001965?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.